An External Manufacturing Technical Operations Consultant is required by CareerWise Recruitment for our multinational pharmaceutical client for a fulltime role on an initial 11-month contract. This role can be fully remote or based in Cork and must be able to travel (25-50%) to EU.
The External Manufacturing Technical Operations Consultant will support the commercial production of sterile drug products at External Partner (EP) sites in Europe including supporting the execution of technology transfers, providing manufacturing process support to resolve commercial production issues, and providing support for process and capacity optimization.
THE ROLE:
* Work with External Partners to achieve business goals and to establish a common culture that benefits our company, External Partners, and patients.
* Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
* Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
* Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
REQUIREMENTS:
* Bachelor’s Degree (Level 8) in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
* Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering.
* Drug product technology transfer experience in Fill Finish and/or Pre-filled Syringe
* Travel will be a requirement of this position at approximately 25-50% in Europe
* Fill Finish/Pre-filled Syringe Experience is a requirement
Please call Laura Gallagher today for further information on 087- 4526468 or email: lgallagher@careerwise.ie
CareerWise Recruitment (In Search of Excellence) Established in 1999, CareerWise Recruitment specialises in recruitment of management and technical professionals for the life sciences, ICT, engineering, food and agri sectors.
We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway, Mayo and Dublin.
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